GxP Lifeline

 

  • Prelude to an FDA Warning Letter

    August 27, 2019 by David Jensen, Staff Writer, MasterControl

    Receiving an FDA warning letter usually sets off a chain reaction of required responses, follow-up tasks and additional correspondence that effectively keeps a regulated company from getting product out the door. This article discusses some of the common reasons life sciences companies receive warning letters and provides tips on how to avoid receiving one.

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  • Q&A: EpiBone on Digitizing and Automating Their Production Records

    August 22, 2019 by David Butcher, Staff Writer, MasterControl

    In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.

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  • 6 Tips for a Successful Transition to the EU MDR

    August 21, 2019 by Jenny Lin, Consultant, Brandwood CKC

    Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.

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  • MasterControl Among 2019 Pharma Innovation Award Winners

    August 20, 2019 by David Jensen, Staff Writer, MasterControl

    Despite some initial hesitancy with advancing technology, health care-related industries are making significant strides in innovation and modernization. The emergence of digitized mobile and wearable medical devices, medical apps and telemedicine technology is evidence that life sciences companies are becoming leading drivers of innovation.

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  • Product Recall Prevention and Recovery: 4 Critical Steps

    August 15, 2019 by James Jardine, Staff Writer, MasterControl

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

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  • EU MDR: How Will Europe’s New Device Regulation Affect Software?

    August 13, 2019 by Camille Bouscaud, Quality Engineer Consultant, Apsalys

    The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.

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  • 5 Quotes From Sun Tzu to Help You Digitize

    August 8, 2019 by Sarah Beale, Staff Writer, MasterControl

    When fighting the War on Paper, it helps to turn to the foremost expert on war. Sun Tzu offers words of wisdom for starting to digitize, getting support from your organization, and how to build upon your successes. Here are five quotes from The Art of War to inspire you to take the battle to your office and permanently get rid of paper.

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  • Top 5 Nutraceutical Trends of 2019 – Pet Supplements

    August 6, 2019 by Sarah Beale, Staff Writer, MasterControl

    Supplements aren’t just for people anymore. The pet supplement market has grown with the human supplement market and there’s every indication that it will continue to do so. Taking advantage of this trend involves producing better quality supplements, conducting clinical research, and embracing technology to improve production.

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  • DIA Global 2019 Recap: 3 Themes Shaping the Future of Life Sciences

    August 1, 2019 by James Jardine, Staff Writer, MasterControl

    Patient centricity, transformative technologies and the importance of high-quality and clinically meaningful data were the major themes at DIA Global 2019. Learn about the trends having the biggest impact on the evolving life sciences landscape.

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  • 5 Ways Digital Technology Will Transform the Supply Chain

    July 30, 2019 by David Butcher, Staff Writer, MasterControl

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

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  • How the Cloud Is Propelling the Golden Age of Life Sciences Startups

    July 25, 2019 by James Jardine, Staff Writer, MasterControl

    By getting FDA approval for its wearable technology just two years after its founding, BraveHeart Wireless is proving that there has never been a better time for startups in the life sciences to embrace cloud technology. Learn how cloud-based solutions are accelerating BraveHeart’s successes.

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  • The New Era of Food Safety Is Digital

    July 23, 2019 by Sarah Beale, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) is looking to build on the Food Safety and Modernization Act (FSMA) to use digitization to improve food safety. This “New Era of Smarter Food Safety” introduces concepts that fully embrace technological innovation and encourage food companies to use digitization to avoid future problems while complying with FSMA.

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  • When Sparks Fly: Conflict Resolution for Quality and Manufacturing

    July 18, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Sparks have long flown between quality and manufacturing, and the adversarial nature of their relationship seems to be an accepted reality. But rarely does the discussion move beyond simply recognizing that a conflict exists. What is the cause of the divide? How can it be bridged? And what do companies stand to gain by doing so?

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  • 3 Quantifiable Benefits Manufacturers Can Achieve by Eliminating Paper

    July 16, 2019 by James Jardine, Staff Writer, MasterControl

    In the manufacturing world, calculable metrics and reproducible outcomes are all that matter. Learn about the three main measurable benefits that manufacturers are realizing by replacing their paper-based processes and production record management practices with fully digitized systems.

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  • Overcoming Challenges in Cannabis Compliance

    July 11, 2019 by Sarah Beale, Staff Writer, MasterControl

    As cannabis legalization spreads, cannabis companies need to ensure they can keep up with their competition and regulations. A quality management system (QMS) gives these businesses the tools they need to overcome their unique challenges.

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  • A Guide for Performing and Maintaining a Validated IT Infrastructure

    July 9, 2019 by Ian Lucas, Partner and Director, SeerPharma

    It’s essential for life sciences and other regulated companies to certify that their IT infrastructure is up to specifications through system validations and qualifications, not only for better compliance, but also to ensure the quality and integrity of their data and production documentation.

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  • 5 Helpful (and Hilarious) Quotes From ‘The Big Lebowski’ That Also ‘Abide’ By Quality

    July 3, 2019 by Mike Rigert, Staff Writer, MasterControl

    “The Big Lebowski,” starring the indefatigable Jeff Bridges, has attracted a cult following over the years. The 1998 film features some of the most quotable lines in film. And, surprise — they apply to the field of quality management.

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  • 10 Ways Cloud Technology Is Reversing a Pharma Trend

    July 2, 2019 by James Jardine, Staff Writer, MasterControl

    Cloud networks, once shunned in the life sciences, have become essential tools for pharmaceutical organizations that want to keep pace with modernized competitors and an increasingly streamlined world. Learn about 10 distinct advantages cloud technology provides to pharma companies.

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  • Avoid FDA Audit Findings on Your Device by Performing Process Validation

    June 27, 2019 by Dan O'Leary, President, Ombu Enterprises

    Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.

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  • Beyond Quality: Leveraging Technology to Build a Quality Culture, Part 2

    June 25, 2019 by James Jardine, Staff Writer, MasterControl

    Quality 4.0 technologies are becoming ever more vital for prosperity. Learn why LNS Research and MasterControl say the experiences of early adopters have laid the groundwork for life sciences companies that are searching for successful industrial transformation (IX) strategies that combine mature technology with a business-first approach.

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